1. The Field of the Invention
This invention relates to apparatus and methods for mastopexy or “breastlift” procedures and devices, and more particularly to devices and methods for increasing stability and longevity of mastopexy operations with augmentation.
2. The Background Art
Plastic and cosmetic surgery has existed for many years as a particular field of medicine, and surgery in particular. Reconstruction after accidents has been developed in order to replace, reconfigure, or otherwise ameliorate damaged tissues subjected to trauma through accident or other causes of disfigurement. In some circumstances, physiological difficulties arise due to damaged, broken, traumatized, or simply disproportionate members of the body. As the skill and experience of medical practitioners has increased, elective surgeries have become more common.
For example, cosmetically, breast enhancement surgeries have become more commonplace. Enhancement procedures may include augmentation of size and shape, as well as selective reduction.
One field of cosmetic surgery involves mastopexy or “breastlift” surgery. Factors such as pregnancy, nursing, physical activity, time, gravity, and the like may affect skin thickness and tone. As skin loses elasticity, shape and firmness consequently decline over time. Breastlift, or mastopexy, is a surgical procedure to raise and reshape breasts. However, no surgery can permanently delay the effects of gravity. Accordingly, mastopexy may alter size, shape, positioning, and volume of breasts. Bio-compatible implants may be inserted under muscle, or under mammary tissues above muscle in order to alter both firmness and size.
The causes of deformation for which mastopexy provides at least a partial remedy may include both stretching of skins and tissues, as well as a loss of elasticity of skins and tissues. Loss of elasticity is a result partly of age, and partly a result of the stretching processes. That is, all materials that are inherently elastic use up part of their elasticity in the process of stretching. Not all stretching is elastic; some is permanent with age, skin tissues are less elastic. Also, underlying tissues may thin, losing fulness and shape. Accordingly, these effects can continue.
Of particular concern is the continued effect of motion and gravity upon on mass subject thereto. Accordingly, continued stretching and drooping may occur after mastopexy. Moreover, in the situation of an augmentation procedure in conjunction with a mastopexy, an implant itself may add additional weight subjecting tissues to further invasion as gravity draws that mass downward. Thus, it would be an advance in the art to provide a method and apparatus to support an implant against the acceleration of gravity, in order to stabilize tissues after a mastopexy operation.
Moreover, complications may occur either unintentionally or simply as a matter of course. For example, any time the body is confronted with a foreign object, even though not chemically or biologically reactive therewith, the body tends to form scar tissue, and wall off the foreign object. Thus, scar tissue may form about an implant. Conventionally, the formation of a scar or a capsule has been relied upon to stabilize the position of an implant. However, implants may rupture, and scar tissue may rupture, altering the containing capsule. Also, the fibroblasts within scar tissue tend to contract. Nature shrinks scars from their initial size as the fibroblasts tend to organize and orient themselves like crystals, and then draw themselves shorter. However, such a contraction of scar tissue in an oblique shape results in closing up the area containing a volume. The result is a tendency toward spherical shape and higher pressures. Thus, texture, firmness, and shape may alter dramatically. What is needed is an apparatus and method for minimizing damage to body tissues, minimizing scarring, as well as an apparatus and method that do not rely on scar tissue formation to maintain dimensional stability temporarily during healing, nor permanently. Positioning is needed that does not wait for the many weeks required for scar tissue to form and stabilize.
Aesthetics may be effected by the reaction of bodily tissues to the presence of an implant. Likewise, alterations in the structure of an implant may also result in undesirable alterations in aesthetics. For example, capsular contracture (scar tissue shrinkage) may not only result in alteration of shape and firmness, but may actually result in rupture of an implant. Likewise, capsular contracture may result in selective shifting of position. Likewise, a rupture of scar tissue may result in shifting the location of an implant.
Thus, for example, what is needed is a system and method for temporary vertical load support in order to relieve the stress on tissues that must heal, in order to minimize scarring. Likewise needed is support for temporary sutures. That is, after surgery, suturing requires time to heal. Scar tissues will increase in width or area if loaded by weight or pressure. Likewise, stress of any wound or a suture location will cause considerable discomfort. Likewise, during scar tissue formation, weight or pressure against scarring tissue will cause additional discomfort.
Likewise, it may be advisable and useful to provide permanent support from weight in order to longer maintain the effects of a successful mastopexy procedure. Also, while many persons are involved in athletic pursuits as a means to recreation or improved health, vertical support against accelerations due to gravity or dynamic motions of an athlete would further enhance and maintain the effects of successful mastopexy.
Scarring responds to loading. If a scar in the skin is subjected to force, the scar will typically respond by localized damage that itself must heal by scarring. Accordingly, scars may be widened during healing by continued stretching or trauma. Moreover, many tissues in the body are comparatively soft. Accordingly, they are restrained by not only their own material properties and surrounding connective tissues but by the support from skin. Accordingly, a load on any particular part of soft tissue may be transferred, much as it would in a liquid, to exert a generalized omni-directional pressure. Thus, gravitational loads on an implant may result in a generalized omni-directional pressure against sutured tissues, causing additional stretching and exacerbation of scars.
It would be an advance in the art to provide vertical support against loading tissues directly as the force of gravity on scars and sutures. It would be an advance as well to provide support generally against the transfer of pressure into tissues in any direction.
As a capsule forms about a foreign body inserted into tissues, scarring forms around the periphery thereof. However, comparatively soft tissues may yield, tear, or otherwise permit migration of a prosthesis or implant. In the absence of other stabilization, and in the presence of unhealed scars, or even after scars have ostensibly formed interior to tissues to stabilize an implant, implants may migrate down or sideways. For example, lateral migration toward the arm, medial migration toward the sternum, downward migration toward the abdomen (inferior), as well as superior migration toward the collarbone, are all possible. In the presence of gravity, most common effects are typically lateral and inferior migration.
Thus, it would be an advance in the art to provide an apparatus and method for maintaining position laterally, medially, inferiorly, and superiorly against migration. Similarly, it would be an advance in the art to provide support against migration loads tending to shift locations of implants due to the stresses of the implant against other tissues during physical activity.
Many persons assume a symmetry to the human body that does not actually exist. Symmetry has been considered by those who study aesthetics to be a particularly pleasing effect. Nevertheless, the human body is not necessarily formed symmetrically. However, the lack of symmetry is still not desirable. Thus, in response to a mastopexy operation, symmetry may be sought as highly desirable. In fact, symmetry may be sought to a degree not originally present. Regardless, it would be an advance in the art to provide line symmetry to the degree possible as a result of mastopexy both along vertical (superior-inferior) lines and horizontal (lateral-medial) lines orthogonal thereto. Thus, positioning implants reliably with respect to one another is desirable, so they are each located along a lateral-medial direction at the same relative location relative to the remainder of the anatomy, positioned in a superior-inferior location equal with respect to one another, and properly located with respect to other anatomical features.
In yet another condition, certain implants are formed of a comparatively soft and resilient solid. Such implants tend to be formed of close-cell foamed polymers. Other implants contain gels. Yet other implants are formed of a shell or skin filled with a saline, glucose, or other solution that will be tolerated and disposed of by the body in the event of exposure to tissues.
The term “microbleed” describes migration of a liquid species through a solid. For example, a silicone liquid or gel may migrate through a wall, causing a reaction with tissues outside an implant. With the use of saline or glucose solutions, any microbleed of materials migrating through a wall of an implant may be absorbed and handled by the body through its normal processes. One result is the decrease of scarring in response to microbleeds of somewhat incompatible materials.
That is, for example, at a molecular or atomic level, chemicals migrate through other chemicals. Thus, an “impervious” material is really not so. Migration is simply very, very slow. Nevertheless, individual atoms, molecules, or the like may migrate through a comparative solid from one surface of a wall to the opposing surface of the wall.
As with all artificial procedures, precision can affect perceived quality of a result. Inasmuch as subsequent relaxation or drooping of tissue may occur after a mastopexy operation, surgeons may overcompensate in advance by “overlifting.” Since the ultimate response of any specific body is a matter of some conjecture, problems may arise with overlifting not subsequently eliminated by additional stretching of tissues under the effects of gravity. Likewise, since tissues in the body are not necessarily identical or symmetrical, a certain degree of symmetry achieved during a lifting or mastopexy operation may be lost subsequently by disproportionate deflection (movement, stretching, etc.) after a mastopexy operation.
What is needed is a system and apparatus for providing mastopexy augmentation that provides a comparatively broad tolerance for a surgeon in the procedure involved, while resulting in a comparatively narrow tolerance or variation in the ultimate outcome. A procedure is needed that provides options for locating an implant, but subsequent, reliable stability.
Textures and dynamic reactions of implants vary. Some implants are formed of comparatively stable and lightweight foamed polymers, whereas others are formed of shells containing comparatively viscous liquids or gels. Yet others are comprised of shells of thin, flexible polymers filled with comparatively inviscid liquids such as saline and glucose.
Much of the driving force behind cosmetic surgery arises from personal valuations of aesthetics. One somewhat unnatural consequence of inviscid fill materials in implants is a dynamic ripple effect in response to motion or acceleration. Dynamic ripples may be visible on the surface of the skin. Dynamic ripples, sometimes called wrinkling, may occur due to the wave-like motion of subcutaneous liquids as filler within an implant.
Soft tissues tend to have a more solidus nature, although soft, and easily deflected. Nevertheless, connective tissues have a certain elasticity present therein providing a certain texture and stability. By contrast, inviscid liquids may result in surface rippling, particular if the implant is only sub-glandular rather than sub-muscular.
Thus, what is needed is an improved apparatus and method providing a simple, reliable, aesthetically appealing mastopexy with augmentation. Reduced side effects, including internal scarring about the capsule surrounding an implant, as well as reduced scarring, stretching, and the like of sutures in the exposed skin would be desirable. Temporary and permanent support of implants, in order to relieve tissues from the forces of gravity in combination with the weight of implants, would be an advance in the art. Stabilization in order to reduce scarring, stiffness, capsular contraction, and scarring in reaction thereto would be an advance in the art.
It would be an advance in the art to reduce microbleed diffusion of filler material by reducing forces or pressures driving such diffusion. Reducing effects of such diffusion should include reducing weight, stress, pressure, and the like tending to strain, stress, damage, or irritate tissues surrounding an implant. It would be an advance in the art to provide increased resistence to inviscid implant fillers by stabilizing the outer shell more substantially, while eliminating or reducing substantially the need for overlifting. Reducing the reliance on scarring as a containment mechanism for the capsule surrounding an implant would likewise advance the art.